Home/Indications/CNS/Major Depressive Disorder

Major Depressive Disorder

CNS 2 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

CNS indication. Major Depressive Disorder has 2 FDA-approved novel treatments, led by FABRE KRAMER across 23 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Major Depressive Disorder Market Leaders

Companies with the most FDA-approved novel Major Depressive Disorder drugs.

Phase 3 Readouts Pro

12 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q3 2026

CYB003

Cybin IRL Limited

Estimated · fresh NCT06564818

Q3 2026

Azetukalner

Xenon Pharmaceuticals Inc.

Estimated · aging NCT06775379

Q3 2026

Dextromethorphan and Bupropion Sustained-Release Tablets

CSPC Ouyi Pharmaceutical Co., Ltd.

Estimated · stale NCT06958692

Unlock 9 more readouts with confidence-graded estimates

Upgrade to Pro

Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Major Depressive Disorder Treatments by Mechanism

Top 10 mechanisms across 32 industry trials with a known mechanism of action.

See full pipeline →

Atypical Antipsychotic

17 trials 7 sponsors

DAT

4 trials 1 sponsor

Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator

3 trials 2 sponsors

Melatonin Receptor Agonist

2 trials 2 sponsors

Dopamine transporter/Norepinephrine transporter

1 trials 1 sponsor

NET/SERT

1 trials 1 sponsor

Progestin Antagonist

1 trials 1 sponsor

Benzodiazepine

1 trials 1 sponsor

Acetylcholine Release Inhibitor

1 trials 1 sponsor

SERT

1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Major Depressive Disorder Clinical Pipeline by Phase

640 industry-sponsored trials across 169 sponsors

Showing 60 of 60 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Neurocrine Biosciences	Valbenazine	—	RECRUITING	2027-01	NCT07105111
Janssen Korea, Ltd., Korea	Esketamine 56 mg	—	RECRUITING	2027-06-25	NCT07053345
Axsome Therapeutics, Inc.	AXS-05	—	RECRUITING	2026-03	NCT06223880
Luye Pharma Group Ltd.	Toludesvenlafaxine Hydrochloride Sustained-release Tablets	—	NOT YET RECRUITING	2027-02-28	NCT06426485
Bausch Health Americas, Inc.	bupropion hydrobromide	Dopamine transporter/Norepinephrine transporter	NOT YET RECRUITING	2029-07	NCT02129751
Neurocrine Biosciences	Valbenazine	—	COMPLETED	2024-12-27	NCT05859698
Johnson & Johnson	Esketamine	—	COMPLETED	2024-07-22	NCT04829318
Johnson & Johnson	Esketamine 56 mg	—	COMPLETED	2024-01-31	NCT04599855
AbbVie	—	—	COMPLETED	2022-12-06	NCT04390581
Teva Branded Pharmaceutical Products R&D, Inc.	Fremanezumab	—	COMPLETED	2022-08-31	NCT04041284
Supernus Pharmaceuticals, Inc.	ZULRESSO®	—	COMPLETED	2022-07-14	NCT05059600
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2022-07-06	NCT04294654
Field Trip Health	—	—	COMPLETED	2022-06-16	NCT05604794
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2022-05-27	NCT04830215
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2022-02-11	NCT04288895
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2022-01-06	NCT04448431
Brainsway	—	—	COMPLETED	2020-07-01	NCT04679753
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2020-02-21	NCT03835715
Takeda	Vortioxetine	—	COMPLETED	2019-03-01	NCT02371980
The Taub Group	Scopolamine and naltrexone	—	COMPLETED	2018-11-20	NCT03386448
Assurex Health Inc.	—	—	COMPLETED	2018-11	NCT02466477
Takeda	Vortioxetine	—	COMPLETED	2018-02-06	NCT02972632
Takeda	Ramelteon	Melatonin Receptor Agonist [EPC]	COMPLETED	2018-01-31	NCT02669082
Lundbeck Canada Inc.	vortioxetine	—	COMPLETED	2017-07-06	NCT02332954
AbbVie	—	—	COMPLETED	2016-12-14	NCT02980783
Forest Laboratories	Levomilnacipran ER	—	COMPLETED	2016-09-16	NCT02288325
Xian-Janssen Pharmaceutical Ltd.	Escitalopram	—	COMPLETED	2015-05	NCT01870843
Forest Laboratories	Vilazodone	—	COMPLETED	2014-10	NCT01573598
Forest Laboratories	Vilazodone	—	COMPLETED	2013-06	NCT01473381
Taiwan Otsuka Pharm. Co., Ltd	Aripiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2013-05	NCT01429831
Eli Lilly	Duloxetine	—	COMPLETED	2013-03	NCT01051466
Forest Laboratories	Vilazodone	—	COMPLETED	2013-02	NCT01473394
Forest Laboratories	Escitalopram	—	COMPLETED	2013-01	NCT01198795
Pfizer	desvenlafaxine succinate sustained-release 50 mg/day	—	COMPLETED	2012-07	NCT01432457
Pfizer	varenicline	—	COMPLETED	2012-06	NCT01078298
Xian-Janssen Pharmaceutical Ltd.	Escitalopram	—	COMPLETED	2012-02	NCT01814085
Pfizer	desvenlafaxine succinate sustained-release	—	COMPLETED	2011-06	NCT01121484
Xian-Janssen Pharmaceutical Ltd.	Escitalopram	—	COMPLETED	2011-05-31	NCT01814098
Eli Lilly	Duloxetine	—	COMPLETED	2011-03	NCT01070329
Eli Lilly	Duloxetine hydrochloride	—	COMPLETED	2011-02	NCT00960986
Pfizer	Desvenlafaxine Succinate Sustained-Release Formulation 50 mg	—	COMPLETED	2011-02	NCT01056289
Eli Lilly	Duloxetine	—	COMPLETED	2010-12	NCT00985504
Eli Lilly	Duloxetine	—	COMPLETED	2010-10	NCT01000805
Pfizer	Desvenlafaxine Succinate Sustained Release	—	COMPLETED	2010-08	NCT00952653
Nang Kuang Pharmaceutical Co., Ltd.	Smilon®	—	COMPLETED	2010-08	NCT01119924
Boehringer Ingelheim	Duloxetine 60 mg QD	—	COMPLETED	2010-06	NCT00844194
Eli Lilly	Duloxetine Hydrochloride	—	COMPLETED	2010-02	NCT00810069
Wyeth is now a wholly owned subsidiary of Pfizer	—	—	COMPLETED	2009-07	NCT00788944
Eli Lilly	Duloxetine	—	COMPLETED	2009-07	NCT00696774
Eli Lilly	duloxetine	—	COMPLETED	2009-02	NCT00666757
Otsuka Pharmaceutical Development & Commercialization, Inc.	Aripiprazole or other oral antipsychotics	—	TERMINATED	2018-10-17	NCT03643159
Novartis	Venlafaxine	—	TERMINATED	2013-09	NCT01436643
GSK	paroxetine 10mg tablet	—	TERMINATED	2011-02	NCT00812812
Rafa Laboratories	hypericum	—	TERMINATED	2010-11	NCT00557427
Alto Neuroscience	Sertraline	—	WITHDRAWN	2023-05-30	NCT04388202
Alto Neuroscience	Duloxetine	—	WITHDRAWN	2023-05-30	NCT04388189
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	WITHDRAWN	2023-03-22	NCT05504486
Sage Therapeutics	Brexanolone	—	WITHDRAWN	2021-08	NCT04273191
GSK	Paroxetine CR	—	WITHDRAWN	2014-09	NCT01916200
Wyeth is now a wholly owned subsidiary of Pfizer	Effexor XR	NET/SERT	WITHDRAWN	2011-10	NCT00878748

Showing 100 of 248 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Cybin IRL Limited	CYB003	—	RECRUITING	2026-08	NCT06564818
Xenon Pharmaceuticals Inc.	Azetukalner	—	RECRUITING	2026-08	NCT06775379
CSPC Ouyi Pharmaceutical Co., Ltd.	Dextromethorphan and Bupropion Sustained-Release Tablets	—	RECRUITING	2026-09-30	NCT06958692
Johnson & Johnson	Seltorexant	—	RECRUITING	2026-12-30	NCT06559306
AbbVie	Cariprazine	—	RECRUITING	2027-03	NCT04777357
Cybin IRL Limited	CYB003	—	RECRUITING	2027-03-18	NCT06793397
Intra-Cellular Therapies, Inc.	Lumateperone	—	RECRUITING	2027-04-05	NCT05850689
Xenon Pharmaceuticals Inc.	Azetukalner	—	RECRUITING	2027-05	NCT07076407
Sunshine Lake Pharma Co., Ltd.	Mitizodone Phosphate tablets	—	RECRUITING	2027-07	NCT04984512
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2027-07	NCT06963021
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2027-07	NCT06911112
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2027-07	NCT06786624
Definium Therapeutics US, Inc.	DT120	—	RECRUITING	2027-09	NCT07592689
Eli Lilly	Brenipatide	—	RECRUITING	2028-02	NCT07412756
Vanda Pharmaceuticals	Milsaperidone	—	RECRUITING	2028-03	NCT06830044
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2028-07	NCT07196501
Johnson & Johnson	Seltorexant	—	RECRUITING	2028-08-24	NCT07573176
Axsome Therapeutics, Inc.	Solriamfetol 150 MG	—	RECRUITING	2028-12	NCT07484217
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2029-05	NCT06966401
Takeda	Vortioxetine tablets	—	RECRUITING	2029-09-30	NCT07204314
Johnson & Johnson	Esketamine	—	RECRUITING	2031-04-09	NCT07227454
Korea Otsuka Pharmaceutical Co., Ltd.	Abilify 2, 5, 10, 15mg (Tablet)	—	RECRUITING	2025-11	NCT03423680
Neumora Therapeutics, Inc.	NMRA-335140	—	ACTIVE NOT RECRUITING	2027-06	NCT06029439
Definium Therapeutics US, Inc.	DT120	—	ACTIVE NOT RECRUITING	2026-05-20	NCT06941844
COMPASS Pathways	Psilocybin	—	ACTIVE NOT RECRUITING	2026-02	NCT05711940
COMPASS Pathways	Psilocybin	—	ACTIVE NOT RECRUITING	2025-05-28	NCT05624268
Tasly Pharmaceutical Group Co., Ltd	JS1-1-01 low-dose group	—	NOT YET RECRUITING	2026-12-31	NCT07485595
NeuroRx, Inc.	NRX-101	—	NOT YET RECRUITING	2027-12-31	NCT07227103
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Ammoxetine	—	NOT YET RECRUITING	2026-06-30	NCT06827431
Neumora Therapeutics, Inc.	NMRA-335140	—	COMPLETED	2026-05-06	NCT06058013
Neumora Therapeutics, Inc.	NMRA-335140	—	COMPLETED	2026-05-04	NCT06058039
Lipocine Inc.	LPCN 1154A	—	COMPLETED	2026-01-16	NCT06979544
Zhejiang Huahai Pharmaceutical Co., Ltd.	Levomilnacipran Hydrochloride Extended-Release Capsules	—	COMPLETED	2025-06-13	NCT07253207
Axsome Therapeutics, Inc.	Solriamfetol 300 mg	—	COMPLETED	2024-12-31	NCT06360419
Neumora Therapeutics, Inc.	NMRA-335140	—	COMPLETED	2024-12-03	NCT06029426
Johnson & Johnson	Aticaprant	—	COMPLETED	2024-11-08	NCT05550532
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2024-10-14	NCT05061719
Johnson & Johnson	Aticaprant	—	COMPLETED	2024-09-18	NCT05455684
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2024-04-12	NCT05061706
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2024-02-22	NCT04985942
Johnson & Johnson	Seltorexant	—	COMPLETED	2023-10-03	NCT04513912
Relmada Therapeutics, Inc.	REL-1017	—	COMPLETED	2023-07-27	NCT04855760
Biogen	SAGE-217	—	COMPLETED	2023-06-22	NCT03864614
Janssen-Cilag, S.A.	Esketamine	—	COMPLETED	2023-06-16	NCT04476446
Johnson & Johnson	Seltorexant	—	COMPLETED	2023-04-25	NCT04533529
Johnson & Johnson	Esketamine Nasal Spray	—	COMPLETED	2022-12-30	NCT02782104
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2022-11-30	NCT04285515
Relmada Therapeutics, Inc.	REL-1017	—	COMPLETED	2022-11-01	NCT04688164
Relmada Therapeutics, Inc.	REL-1017	—	COMPLETED	2022-09-13	NCT05081167
AbbVie	Cariprazine	—	COMPLETED	2022-09-05	NCT03573297
Mochida Pharmaceutical Company, Ltd.	Desvenlafaxine 100 mg	—	COMPLETED	2022-07-21	NCT04345471
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2022-07-08	NCT03538691
Otsuka Pharmaceutical Co., Ltd.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2022-06-06	NCT03697603
Praxis Precision Medicines	PRAX-114	—	COMPLETED	2022-05-05	NCT04832425
Biogen	SAGE-217	—	COMPLETED	2022-03-15	NCT04442503
H. Lundbeck A/S	Vortioxetine 10 mg/day	—	COMPLETED	2022-01-21	NCT02709655
Janssen-Cilag International NV	Esketamine 28 mg	—	COMPLETED	2022-01-20	NCT04338321
Biogen	SAGE-217	—	COMPLETED	2021-10-25	NCT04476030
AbbVie	Cariprazine	—	COMPLETED	2021-09-30	NCT03738215
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Duloxetine Hydrochloride Enteric-coated Capsule	—	COMPLETED	2021-09-22	NCT04364997
AbbVie	Cariprazine	—	COMPLETED	2021-09-06	NCT03739203
Johnson & Johnson	Esketamine 56 mg	—	COMPLETED	2021-04-13	NCT03434041
Biogen	SAGE-217	—	COMPLETED	2021-03-26	NCT04442490
Otsuka Pharmaceutical Co., Ltd.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2021-03-17	NCT03737474
AbbVie	Levomilnacipran ER	—	COMPLETED	2021-03-01	NCT03569475
Supernus Pharmaceuticals, Inc.	Brexanolone	—	COMPLETED	2021-01-08	NCT03665038
Luye Pharma Group Ltd.	LY03005 extended-release tablet	—	COMPLETED	2020-12-24	NCT04853407
Axsome Therapeutics, Inc.	AXS-05 (dextromethorphan and bupropion) oral tablets	—	COMPLETED	2020-10-23	NCT04039022
ACADIA Pharmaceuticals Inc.	Pimavanserin	—	COMPLETED	2020-04-30	NCT03968159
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2020-04-16	NCT03108625
Axsome Therapeutics, Inc.	AXS-05	—	COMPLETED	2020-03-20	NCT02741791
Alkermes, Inc.	ALKS 5461	—	COMPLETED	2020-02-26	NCT03188185
Axsome Therapeutics, Inc.	AXS-05	—	COMPLETED	2019-11-26	NCT04019704
Shionogi	Duloxetine Hydrochloride	—	COMPLETED	2019-11-08	NCT03315793
Biogen	SAGE-217	—	COMPLETED	2019-09-24	NCT03672175
Forest Laboratories	Levomilnacipran	—	COMPLETED	2019-08-19	NCT02431806
H. Lundbeck A/S	Vortioxetine 10 mg/day	—	COMPLETED	2019-07-02	NCT02709746
Johnson & Johnson	Esketamine	—	COMPLETED	2019-04-11	NCT03097133
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2019-02-22	NCT02951988
Johnson & Johnson	Esketamine	—	COMPLETED	2018-12-18	NCT03039192
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2018-12-12	NCT02943564
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2018-12-06	NCT03002077
Biogen	SAGE-217 15/20 mg Oral Solution	—	COMPLETED	2018-11-15	NCT02978326
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2018-10-26	NCT02943577
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2018-09-21	NCT02932943
Forest Laboratories	Vilazodone	—	COMPLETED	2018-09-11	NCT02372799
Forest Laboratories	Vilazodone	—	COMPLETED	2018-07-23	NCT02436239
Takeda	Vortioxetine	—	COMPLETED	2018-03-16	NCT02389816
Johnson & Johnson	Esketamine	—	COMPLETED	2018-02-20	NCT02417064
Johnson & Johnson	Esketamine	—	COMPLETED	2018-02-15	NCT02493868
Forest Laboratories	Cariprazine	—	COMPLETED	2018-01-18	NCT02670538
Alkermes, Inc.	ALKS 5461	—	COMPLETED	2017-11-20	NCT02141399
Johnson & Johnson	Esketamine (Intranasal Spray)	—	COMPLETED	2017-10-28	NCT02497287
Supernus Pharmaceuticals, Inc.	SAGE-547 60 μg/kg/h	—	COMPLETED	2017-09-24	NCT02942004
Supernus Pharmaceuticals, Inc.	SAGE-547 90 μg/kg/h	—	COMPLETED	2017-09-17	NCT02942017
Johnson & Johnson	Esketamine	—	COMPLETED	2017-08-10	NCT02422186
Forest Laboratories	Cariprazine	—	COMPLETED	2017-07-19	NCT02670551
Johnson & Johnson	Esketamine	—	COMPLETED	2017-06-01	NCT02418585
Otsuka Pharmaceutical Development & Commercialization, Inc.	OPC-34712	—	COMPLETED	2017-04-18	NCT01360866
Ybrain Inc.	—	—	COMPLETED	2016-12	NCT02657980

Showing 100 of 207 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
atai Therapeutics, Inc.	VLS-01-203 BU	—	RECRUITING	2026-08-01	NCT06524830
Gilgamesh Pharmaceuticals	GM-2505	—	RECRUITING	2026-10	NCT06236880
Beckley Psytech Limited	BPL-003	—	RECRUITING	2026-11	NCT05660642
Alto Neuroscience	ALTO-300	—	RECRUITING	2026-12	NCT05922878
Mapi Pharma Ltd.	Cariprazine Depot	—	RECRUITING	2026-12-31	NCT07185815
Supernus Pharmaceuticals, Inc.	SPN-821 2400 mg	—	RECRUITING	2026-12-31	NCT07226661
Seaport Therapeutics	SPT-300	—	RECRUITING	2027-03	NCT07065240
Draig Therapeutics Ltd	DT-101	—	RECRUITING	2027-05	NCT07610473
ACADIA Pharmaceuticals Inc.	ACP-211	—	RECRUITING	2027-08	NCT07284667
Draig Therapeutics Ltd	DT-101	—	RECRUITING	2027-08	NCT07300969
AbbVie	Icalcaprant	—	RECRUITING	2027-09	NCT07276997
Syndeio Biosciences, Inc	Zelquistinel	—	RECRUITING	2027-09	NCT06547489
Alto Neuroscience	ALTO-207	—	RECRUITING	2027-11	NCT07553637
Tonix Pharmaceuticals, Inc.	TNX-102 SL	—	RECRUITING	2028-02	NCT07621237
Syndeio Biosciences, Inc	Zelquistinel	—	RECRUITING	2028-03-30	NCT07115329
Sichuan Purity Pharmaceutical Technology Co., Ltd.	Low Dose PRT042 nasal spray	—	RECRUITING	2026-06	NCT07193901
Autobahn Therapeutics, Inc.	ABX-002	—	RECRUITING	2026-06	NCT06633016
Hangzhou PhecdaMed Co., Ltd.	TJ0113	—	RECRUITING	2026-05-25	NCT07018245
Sirtsei Pharmaceuticals, Inc.	SP-624	—	ACTIVE NOT RECRUITING	2026-07-15	NCT06254612
Johnson & Johnson	JNJ-89495120	—	ACTIVE NOT RECRUITING	2026-06-25	NCT06785012
Autobahn Therapeutics, Inc.	ABX-002	—	ACTIVE NOT RECRUITING	2026-04-22	NCT06869187
Chase Therapeutics Corporation	CTC-501	—	ACTIVE NOT RECRUITING	2025-12-30	NCT03642964
Eleusis Therapeutics	ELE-101	—	ACTIVE NOT RECRUITING	2025-12	NCT05434156
COMPASS Pathways	Psilocybin	—	ACTIVE NOT RECRUITING	2025-09	NCT05733546
Chengdu Kanghong Pharmaceutical Group Co., Ltd.	KH607 tablet	—	NOT YET RECRUITING	2027-01	NCT07096791
Afasci Inc	AFA-281	—	NOT YET RECRUITING	2027-06-01	NCT06710431
Enalare Therapeutics Inc.	ENA-001	—	NOT YET RECRUITING	2027-06-15	NCT06137638
Neurocentrx Pharma Pty Ltd	KET-AD	—	NOT YET RECRUITING	2028-01-30	NCT07644767
BioLite, Inc.	PDC-1421 Capsule	—	NOT YET RECRUITING	2028-02-28	NCT03833206
Soterix Medical	—	—	NOT YET RECRUITING	2028-06-01	NCT07287839
Chengdu Kanghong Pharmaceutical Group Co., Ltd.	KH607 tablets	—	NOT YET RECRUITING	2025-12	NCT07101120
Ono Pharmaceutical Co., Ltd.	ONO-1110	—	COMPLETED	2026-04-09	NCT06792136
Biohaven Therapeutics Ltd.	BHV-7000	—	COMPLETED	2026-03-18	NCT06423781
Suven Life Sciences Limited	Ropanicant	—	COMPLETED	2026-02-23	NCT06836063
Biohaven Therapeutics Ltd.	BHV-7000	—	COMPLETED	2025-11-07	NCT06419608
Otsuka Pharmaceutical Development & Commercialization, Inc.	SEP-363856	—	COMPLETED	2025-11-06	NCT05593029
DuKang Pharmaceuticals, Inc.	NORA520 Dose 1	—	COMPLETED	2025-09-11	NCT06285916
Nanjing Minova Pharmaceutical Co., Ltd.	MI078 capsule dose 1	—	COMPLETED	2025-08-07	NCT06963580
Jiangsu Nhwa Pharmaceutical Co., Ltd.	NH102	—	COMPLETED	2025-07-30	NCT06842992
Neurocrine Biosciences	NBI-1070770	—	COMPLETED	2025-07-25	NCT06267846
Clexio Biosciences Ltd.	CLE-100	—	COMPLETED	2025-06-06	NCT06340958
Reunion Neuroscience Inc	RE104 for Injection	—	COMPLETED	2025-05-22	NCT06342310
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine	—	COMPLETED	2025-05-16	NCT05536414
Boehringer Ingelheim	5 mg BI 1569912	—	COMPLETED	2025-05-02	NCT06558344
Alto Neuroscience	ALTO-203 25 μg	—	COMPLETED	2025-04-14	NCT06391593
Beckley Psytech Limited	BPL-003	—	COMPLETED	2025-03-28	NCT05870540
Gilgamesh Pharmaceuticals	GM-1020	—	COMPLETED	2025-03-04	NCT06309277
Boehringer Ingelheim	BI 1569912	—	COMPLETED	2025-02-26	NCT06280235
Biomind Labs Inc.	Sublingual administration	—	COMPLETED	2025-02-15	NCT06812221
Navitor Pharmaceuticals, Inc.	NV-5138	—	COMPLETED	2025-01-21	NCT05066672
Mapreg	MAP4343	—	COMPLETED	2024-11-07	NCT03870776
Tasly Pharmaceutical Group Co., Ltd	JS1-1-01 low-dose group	—	COMPLETED	2024-10-23	NCT06259526
GH Research Ireland Limited	GH001	—	COMPLETED	2024-10-04	NCT05800860
Alto Neuroscience	ALTO-100	—	COMPLETED	2024-09-05	NCT05712187
Navitor Pharmaceuticals, Inc.	NV-5138	—	COMPLETED	2024-08-18	NCT06235905
Suven Life Sciences Limited	Ropanicant	—	COMPLETED	2024-07-19	NCT06126497
Actinogen Medical	Xanamem™	—	COMPLETED	2024-07-01	NCT05657691
Brii Biosciences Limited	BRII-296	—	COMPLETED	2024-03-13	NCT06057012
Denovo Biopharma LLC	Liafensine	—	COMPLETED	2024-02-06	NCT05113771
Boehringer Ingelheim	BI 1358894	—	COMPLETED	2024-01-10	NCT04521478
Neurocrine Biosciences	NBI-1065845	—	COMPLETED	2024-01-10	NCT05203341
Novartis	MIJ821 Subcutaneous Injection 1 mg	—	COMPLETED	2023-11-28	NCT05454410
Cybin IRL Limited	CYB003	—	COMPLETED	2023-10-16	NCT05385783
Tonix Pharmaceuticals, Inc.	TNX-601 ER	—	COMPLETED	2023-09-29	NCT05686408
Beijing Greatway Pharmaceutical Technology Co.,Ltd.	GW117 Tablets	—	COMPLETED	2023-09-28	NCT06796868
Xenon Pharmaceuticals Inc.	XEN1101 10 mg	—	COMPLETED	2023-09-18	NCT05376150
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.	ANC-501	—	COMPLETED	2023-08-14	NCT05439603
Neurocrine Biosciences	NBI-1065846	—	COMPLETED	2023-07-07	NCT05165394
Seelos Therapeutics, Inc.	SLS-002	—	COMPLETED	2023-06-17	NCT04669665
Alto Neuroscience	ALTO-300 oral (PO) tablet	—	COMPLETED	2023-05-05	NCT05118750
Alto Neuroscience	ALTO-300 PO Tablet	—	COMPLETED	2023-04-26	NCT05157945
Johnson & Johnson	Midazolam	Benzodiazepine [EPC]	COMPLETED	2023-03-31	NCT03185819
Alto Neuroscience	ALTO-100 PO Tablet	—	COMPLETED	2023-01-13	NCT05419869
Alto Neuroscience	ALTO-100 PO tablet	—	COMPLETED	2022-12-01	NCT05117632
Perception Neuroscience	PCN-101	—	COMPLETED	2022-11-10	NCT05414422
Small Pharma Ltd	SPL026	—	COMPLETED	2022-10-01	NCT04673383
Clexio Biosciences Ltd.	CLE-100	—	COMPLETED	2022-09-21	NCT04103892
Praxis Precision Medicines	10 mg PRAX-114	—	COMPLETED	2022-07-15	NCT04969510
Sirtsei Pharmaceuticals, Inc.	SP-624	—	COMPLETED	2022-06-27	NCT04479852
Neumora Therapeutics, Inc.	NMRA-335140	—	COMPLETED	2022-04-08	NCT04221230
Otsuka Pharmaceutical Co., Ltd.	OPC-64005 20 mg , Once-daily	—	COMPLETED	2022-02-08	NCT04244253
GH Research Ireland Limited	5 Methoxy N,N Dimethyltryptamine	—	COMPLETED	2021-11-06	NCT04698603
COMPASS Pathways	Psilocybin	—	COMPLETED	2021-10-14	NCT04739865
Johnson & Johnson	JNJ-61393215	—	COMPLETED	2021-09-02	NCT04080752
COMPASS Pathways	Psilocybin	—	COMPLETED	2021-07-30	NCT03775200
Axsome Therapeutics, Inc.	AXS-05	—	COMPLETED	2021-07-30	NCT04608396
Johnson & Johnson	JNJ-67953964	—	COMPLETED	2020-05-06	NCT03559192
Sumitomo Pharma America, Inc.	SEP-4199 200 mg	—	COMPLETED	2020-04-23	NCT03543410
Novartis	MIJ821	—	COMPLETED	2020-03-23	NCT03756129
Celon Pharma SA	Esketamine DPI - low dose	—	COMPLETED	2020-03-15	NCT03965858
Zhejiang Huahai Pharmaceutical Co., Ltd.	Hypidone Hydrochloride tablets	—	COMPLETED	2019-12-18	NCT03739632
Minerva Neurosciences	MIN-117 5.0 mg	—	COMPLETED	2019-11-21	NCT03446846
Syndeio Biosciences, Inc	AGN-241751	—	COMPLETED	2019-10-23	NCT03726658
VistaGen Therapeutics, Inc.	AV-101	—	COMPLETED	2019-10-01	NCT03078322
Janssen Pharmaceutical K.K.	Intranasal esketamine (28 mg)	—	COMPLETED	2019-08-19	NCT02918318
H. Lundbeck A/S	Vortioxetine infusion 25 mg	—	COMPLETED	2019-07-31	NCT03766867
Relmada Therapeutics, Inc.	REL-1017	—	COMPLETED	2019-07-30	NCT03051256
Syndeio Biosciences, Inc	AGN-241751	—	COMPLETED	2019-07-22	NCT03586427
Marinus Pharmaceuticals	Ganaxolone	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]	COMPLETED	2019-07-05	NCT03460756
Avid Radiopharmaceuticals	Flortaucipir F18	—	COMPLETED	2019-06-26	NCT02278367

Showing 100 of 125 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Enalare Therapeutics Inc.	ENA-001	—	RECRUITING	2026-07-30	NCT06967259
Corium Innovations, Inc.	Selegiline Transdermal Delivery System	—	NOT YET RECRUITING	2026-10-07	NCT07452692
Soterix Medical	Ketamine (0.25 mg/kg)	—	NOT YET RECRUITING	2027-12-01	NCT07307768
Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.	SP-101 injection	—	NOT YET RECRUITING	2026-06-30	NCT07334249
Nyree Penn	Diprivan (propofol), Astra-Zeneca	—	NOT YET RECRUITING	2026-05-01	NCT06644573
Sirtsei Pharmaceuticals, Inc.	SP-624	—	COMPLETED	2026-05-11	NCT06570369
Alar Pharmaceuticals Inc.	ALA-3000	—	COMPLETED	2025-12-30	NCT06965569
Engrail Therapeutics INC	ENX-104	—	COMPLETED	2025-11-26	NCT07253324
Otsuka Pharmaceutical Development & Commercialization, Inc.	SEP-380135	—	COMPLETED	2025-09-12	NCT07549581
Vigonvita Life Sciences	LV232 40mg	—	COMPLETED	2025-01-19	NCT06476509
Biogen	Zuranolone	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]	COMPLETED	2024-10-18	NCT05655507
Nanjing Minova Pharmaceutical Co., Ltd.	MI078	—	COMPLETED	2024-03-18	NCT06982651
Brii Biosciences Limited	BRII-297	—	COMPLETED	2023-11-21	NCT05845840
Boehringer Ingelheim	BI 1569912	—	COMPLETED	2023-11-16	NCT04937829
Novartis	MIJ821	—	COMPLETED	2023-11-07	NCT05666687
Small Pharma Ltd	SPL026	—	COMPLETED	2023-08-03	NCT05553691
Jiangsu Nhwa Pharmaceutical Co., Ltd.	NH102	—	COMPLETED	2023-04-10	NCT07324408
Small Pharma Ltd	SPL026 IV	—	COMPLETED	2023-04-05	NCT05644093
Syndeio Biosciences, Inc	apimostinel	—	COMPLETED	2023-04-04	NCT05597241
Beijing Greatway Pharmaceutical Technology Co.,Ltd.	GW117 ODT	—	COMPLETED	2023-03-24	NCT06964711
Johnson & Johnson	Seltorexant Dose 1	—	COMPLETED	2023-03-16	NCT04451187
Jiangsu Hansoh Pharmaceutical Co., Ltd.	HS-10353	—	COMPLETED	2023-03-11	NCT05195203
Seasons Biotechnology (Taizhou) Co., Ltd.	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 5mg	—	COMPLETED	2022-11-25	NCT05416762
Digestome Therapeutics	DGX-001Dose 1	—	COMPLETED	2022-11-06	NCT05121831
Seasons Biotechnology (Taizhou) Co., Ltd.	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets	—	COMPLETED	2022-10-27	NCT05416957
Luye Pharma Group Ltd.	LY03010 156 mg treatment group, deltoid	—	COMPLETED	2022-09-23	NCT05321602
Seasons Biotechnology (Taizhou) Co., Ltd.	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets	—	COMPLETED	2022-09-02	NCT05417087
Soterix Medical	—	—	COMPLETED	2022-08-10	NCT04781127
Jiangsu Hansoh Pharmaceutical Co., Ltd.	HS-10345 84mg	—	COMPLETED	2022-04-30	NCT05196971
Jiangsu Nhwa Pharmaceutical Co., Ltd.	NH102	—	COMPLETED	2022-01-11	NCT05015192
Jiangsu HengRui Medicine Co., Ltd.	HR071603	—	COMPLETED	2021-06-01	NCT04108234
Zhejiang Huahai Pharmaceutical Co., Ltd.	Hypidone Hydrochloride tablets	—	COMPLETED	2021-01-11	NCT04598607
Sunshine Lake Pharma Co., Ltd.	HEC113995	—	COMPLETED	2020-08-12	NCT04623814
Sunshine Lake Pharma Co., Ltd.	HEC113995 PA•H2O tablets	—	COMPLETED	2019-12-06	NCT04591301
BioDelivery Sciences International	Belbuca 300 µg	—	COMPLETED	2019-10-27	NCT03996694
Boehringer Ingelheim	BI 1358894	—	COMPLETED	2019-08-27	NCT03854578
Navitor Pharmaceuticals, Inc.	NV-5138	—	COMPLETED	2019-06-09	NCT03606395
Johnson & Johnson	JNJ-42847922 20mg	—	COMPLETED	2019-04-29	NCT03374475
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2019-02-16	NCT03822065
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2018-07-17	NCT03733574
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Ammoxetine Hydrochloride Enteric-coated Tablets	—	COMPLETED	2018-07-11	NCT03456388
Suven Life Sciences Limited	SUVN-911	—	COMPLETED	2018-07-10	NCT03551288
Johnson & Johnson	Esketamine	—	COMPLETED	2018-06-29	NCT02919579
Suven Life Sciences Limited	SUVN-911	—	COMPLETED	2018-03-07	NCT03155503
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2017-12-22	NCT03357796
Syndeio Biosciences, Inc	zelquistinel	—	COMPLETED	2017-12-21	NCT04981561
Lee's Pharmaceutical Limited	Trazodone Hydrochloride prolonged-release tablets	—	COMPLETED	2017-11-30	NCT02785601
Lee's Pharmaceutical Limited	trazodone hydrochloride prolonged-release tablet	—	COMPLETED	2017-11-30	NCT02785614
Neurocrine Biosciences	TAK-653	—	COMPLETED	2017-09-11	NCT02561156
Johnson & Johnson	JNJ-54175446, 600 mg	—	COMPLETED	2017-06-02	NCT02902601
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2016-12-28	NCT02988024
GSK	Bupropion HCl XL tablet 150mg	—	COMPLETED	2016-06-29	NCT02698553
Janssen-Cilag International NV	JNJ-42847922	—	COMPLETED	2016-01-04	NCT02476058
Luye Pharma Group Ltd.	LY03005 extended-release tablets 40 mg	—	COMPLETED	2015-10-31	NCT03785652
Roche	Basimglurant	—	COMPLETED	2015-09	NCT02433093
Naurex, Inc, an affiliate of Allergan plc	NRX-1074 375 mg	—	COMPLETED	2015-04	NCT02366364
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2015-03	NCT02271412
P1vital Products Limited	—	—	COMPLETED	2015-01	NCT02800577
Johnson & Johnson	JNJ-42847922	—	COMPLETED	2014-12	NCT02067299
Johnson & Johnson	Aripiprazole, oral formulation	—	COMPLETED	2014-10	NCT02087579
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2014-08	NCT02055300
Neuralstem Inc.	NSI-189 Phosphate	—	COMPLETED	2014-02	NCT01520649
H. Lundbeck A/S	Vortioxetine (Lu AA21004)	—	COMPLETED	2013-09	NCT01607125
BioLite, Inc.	PDC-1421	—	COMPLETED	2013-07	NCT01774045
MSI Methylation Sciences, Inc.	Ademetionine	—	COMPLETED	2013-06-08	NCT04623034
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2013-05	NCT01670279
Eli Lilly	LY2216684	—	COMPLETED	2012-08	NCT01460381
Astellas	FK949E	—	COMPLETED	2012-06-22	NCT01919008
Bristol-Myers Squibb	BMS-820836	—	COMPLETED	2012-05	NCT01396252
Eli Lilly	LY2216684	—	COMPLETED	2011-12	NCT01373931
Eli Lilly	LY2216684	—	COMPLETED	2011-12	NCT01460407
Pfizer	desvenlafaxine	—	COMPLETED	2011-12	NCT01443208
BlackThorn Therapeutics, Inc.	LY2940094	—	COMPLETED	2011-11	NCT01404091
Neuralstem Inc.	NSI-189 Phosphate	—	COMPLETED	2011-11	NCT01310881
Eli Lilly	LY2216684	—	COMPLETED	2011-09	NCT01380691
Eli Lilly	LY2216684	—	COMPLETED	2011-09	NCT01389752
AbbVie	ABT-436	—	COMPLETED	2011-09	NCT01380704
Astellas	FK949E	—	COMPLETED	2011-09	NCT01903200
BlackThorn Therapeutics, Inc.	LY2940094	—	COMPLETED	2011-09	NCT01263236
Eli Lilly	LY2216684	—	COMPLETED	2011-08	NCT01389765
Dong Wha Pharmaceutical Co. Ltd.	DWETR10	—	COMPLETED	2011-08	NCT01367080
Astellas	FK949E	—	COMPLETED	2011-05	NCT01924520
Eli Lilly	LY2216684	—	COMPLETED	2011-04	NCT01241435
Eli Lilly	LY2216684	—	COMPLETED	2011-03	NCT01263197
Eli Lilly	LY2216684	—	COMPLETED	2011-03	NCT01263223
Eli Lilly	Clopidogrel	—	COMPLETED	2011-03	NCT01263093
AstraZeneca	AZD6765	—	COMPLETED	2011-03	NCT01046630
Eli Lilly	LY2216684	—	COMPLETED	2011-02	NCT01275144
Eli Lilly	Warfarin	—	COMPLETED	2011-02	NCT01263119
Eli Lilly	LY2216684	—	COMPLETED	2011-02	NCT01266590
Eli Lilly	LY2216684	—	COMPLETED	2011-01	NCT01263106
Eli Lilly	LY2216684	—	COMPLETED	2011-01	NCT01243957
Eli Lilly	LY2216684	—	COMPLETED	2011-01	NCT01250873
Pfizer	desvenlafaxine succinate sustained release	—	COMPLETED	2010-11	NCT01190514
Bristol-Myers Squibb	BMS-820836	—	COMPLETED	2010-11	NCT00892840
AstraZeneca	—	—	COMPLETED	2010-10	NCT01217645
CeNeRx BioPharma Inc.	CX157	—	COMPLETED	2010-10	NCT01633437
GSK	Aripiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2010-07	NCT01424449
Novartis	ABP688	—	COMPLETED	2010-05	NCT01528241
GSK	GSK356278	—	COMPLETED	2010-04-07	NCT01031186

Novel Major Depressive Disorder Drugs by Company (New molecular entities)

2 companies have an FDA-approved novel drug for Major Depressive Disorder.

FABRE KRAMER 1 drug

EXXUA

GEPIRONE HYDROCHLORIDE

NDA 2023

Johnson & Johnson 1 drug

SPRAVATO

ESKETAMINE HYDROCHLORIDE

NDA 2019

Reformulations (25 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.